Editing subject data

You can correct inaccurate subject information in any editable field.

Changes to subject information could require approval. If the field is marked with an asterisk (*), changes to the field must be approved. The subject's record is locked () until the approver makes a decision, and you cannot give the drug units to the subject until approval is received. If the situation is urgent, contact the approver. For more information, see Checking the status of an approval request.

Click Subjects ().
On the left, click Subject Transactions.
Find the subject in the list.
Click to the left of the subject number, or select the row with the subject you want to view.
Select the Visit Name for the date of the previous visit you want to correct.

Edit the subject information as required:

Fields in the Edit Subject Data section

In the Comment to Approver text area, type a comment about the edits you made.
In the Need By Date drop-down list, select the date by which you need approval for the changes.
Click Submit.
IRT sends you an email to let you know whether the changes are approved. If approval is granted, the email also lists the changes you made to the subject information.
Print the email, and file the printed copy according to the policies of the study.

Field	Description	Notes

Edit Subject Data
Field Description	The name of the field that was corrected. If the field is marked with an asterisk (*), the field requires approval for editing. A subject affected by a request for approval is locked () until the request is reviewed and either approved or rejected.	READ-ONLY
Dependencies	Other transactions that are affected by the transaction where the data was corrected. This field is informational only.	READ-ONLY
Current Value	The value of the field that was logged during the visit.	READ-ONLY
New Value	The corrected values of the fields.
Reason for Change	The reason for changing the data. Provide a reason for each field in the New Value column.	REQUIRED. Maximum length: 4000 characters